FDA grants denosumab priority review for cancer-related bone loss

Earlier this year, the drug was approved for the treatment of osteoporosis in postmenopausal women.

The FDA has granted denosumab, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures, priority review status for the treatment of bone metastases to reduce skeletal-related events in patients with advanced cancer.

Denosumab (Prolia, Amgen) is a RANK Ligand inhibitor, available as a 60-mg subcutaneous injection once every six months.

Priority review, given to drugs that offer major advances or provide a treatment in which no adequate treatment exists, means that the FDA will schedule an agency action on Amgen’s Biologics License Application within 6 months. Amgen filed the application in May.

The FDA will consider data on nearly 6,900 patients from 18 clinical sites, including approximately 5,700 patients with advanced cancer in the three phase 3 head-to-head trials vs. zoledronic acid (Zometa, Novartis).

In August 2009, the FDA Advisory Committee for Reproductive Health Drugs did not recommend the approval of denosumab for the prevention of bone loss in patients with breast or prostate cancer. However, at the same meeting, the committee also voted against the use of denosumab for preventive use in postmenopausal osteoporosis, an indication that the drug was approved for in May.

In June, the drug was approved with a Risk Evaluation and Mitigation Strategy (REMS) that includes a Medication Guide for patients and communications to health care providers that explains the risks and benefits of denosumab.

Although the FDA is not required to follow the recommendation of its advisory committees, it usually does.

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